These inaccurate and misleading statements are often made without proper context, and are intended to be sensational, to create fear or to generate headlines. In many instances, these statements are not supported by scientific facts or medical evidence. and some states' capitals. SAN DIEGO - Rampant misinformation about Zohydro ER continues to be reported by the media and echoed in Washington D.C.
FACT: Zogenix has implemented voluntary initiatives, educational tools and safeguards, which began prior to making Zohydro ER available, unlike the introduction of opioids in the past. The Bottom Line.
Over the coming weeks, we will continue to report and distribute accurate information to address common misperceptions about Zohydro ER. Zohydro ER deserves to be judged on its medical merits and the benefits it provides to patients suffering from chronic pain, not on the basis of media reports.
FACT: In comparison to other opioids, the amount of Zohydro ER that will be available represents less than 0.3 percent of the total quantity available of the majority of opioid pills/capsules in 2014.
The availability of an acetaminophen-free formulation of extended release hydrocodone, therefore, is an important therapeutic option for certain chronic pain patients. Acetaminophen overdose is a leading cause of acute liver failure in the U.S., with 63 percent of unintentional acetaminophen overdoses attributed to the use of opioid-acetaminophen combination products.
"It's been said that Zohydro is super-potent. That surprises me because the highest dosage unit of Zohydro extended release is lower than the highest dosage unit of all the other available extended release products on a milligram basis.".
FACT: Zohydro ER is equally as potent as oxycodone (the active ingredient in OxyContin); and less potent than many other commonly prescribed opioids including oxymorphone, hydromorphone and fentanyl on a per milligram basis.
"Right now, unfortunay, the technology is poor.". "I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction," Hamburg told lawmakers.
FACT: Only one of more than thirty extended release opioids and none of the immediate release opioids have FDA approved labeling for abuse deterrent properties.
We are dedicated to responsibly serving people suffering with severe chronic pain and the health care professionals who treat them, while doing our very best to set a new standard of transparency and commitment in delivering on our promise to patients. On behalf of patients and the doctors who serve them, Zogenix will continue to demand due process and fair treatment for our medications and our company.
The fact is that Zohydro ER is a novel pain medicine that fills an important medical need—a hydrocodone medicine for severe chronic pain that can be taken twice a day, instead of 4-6 times a day, and that does not contain acetaminophen, which carries significant risk of liver toxicity when used for long periods of time. Food and Drug Administration (FDA) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER is the first and only extended-release hydrocodone without acetaminophen approved by the U.S.
FACT: The highest dosage strength of Zohydro ER is lower than the highest dosage strength of OxyContin and other commonly prescribed extended-release opioids on a per milligram basis.
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FACT: In 2013, 98 percent of total opioid prescriptions were written for opioids that do not have FDA approved abuse deterrent properties.
In fact, doing a similar comparison of the highest dosage strength of commonly prescribed extended release opioids to the lowest dosage strength of their immediate release versions shows that Zohydro ER actually has the lowest difference in single tablet dosage strength as compared to its related immediate release formulation. As shown in the table below, this is true for all extended-release opioids.
FACT: Zohydro ER (extended release hydrocodone capsules without acetaminophen) is no more potentthan Vicodin (or other immediate release hydrocodone tablets with acetaminophen) on a per milligram basis.Oxycodone milligrams